The Gut Microbiota in Obsessive-Compulsive Disorder

NCT02285699 | Completed

• 1 other identifier: 14-722
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine the gut microbiota and serum inflammatory markers in patients with Obsessive-Compulsive Disorder vs. healthy controls. Phase II of the study will examine the gut microbiota and cytokine levels following 12-weeks of treatment with Selective Serotonin Reuptake Inhibitors (SSRIs).

Conditions

Obsessive-Compulsive Disorder

Keywords

Selective Serotonin Reuptake Inhibitors

Outcome Measures

Primary Outcomes (2)

• Yale Brown Obsessive Compulsive Scale

  12 weeks

• Clinical Global Impression - Improvement

  12 weeks

Secondary Outcomes (4)

• Obsessive-Compulsive Inventory - Revised (OCI-R)

  12 weeks

• Dutch Dimensional Obsessive Compulsive Scale (DDOCS)

  12 weeks

• Depression Anxiety Stress Scale (DASS-21)

  12 weeks

• Anti-Cancer Council of Victoria Food Frequency Questionnaire

  12 weeks

Study Arms (1)

SSRI treatment

OTHER

The intervention only applies to Phase II of the proposed study. Individuals in the OCD group will be offered 12-weeks of standard SSRI treatment ti determine whether 12-weeks of treatment results in a change of the gut microbiota/inflammatory markers.

Drug: SSRIs

Interventions

SSRIs DRUG

12-weeks of standard SSRi treatment for those interested in Phase II of the study.

Also known as: Fluoxetine, Paroxetine, Fluvoxamine, Escitalopram, Citalopram, Sertraline

SSRI treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a primary diagnosis of OCD (DSM 5) according to the MINI
• Y-BOCS score of ≥20.
• MADRS \< 18

You may not qualify if:

• Participants with current Major Depressive Disorder.
• Patients with significant suicidal ideation (MADRS item 10 ≥ 3) or who have enacted suicidal behaviors within 6 months prior to intake will be excluded from study participation and referred for appropriate clinical intervention.
• Individuals with current autoimmune disorders (rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, etc.), inflammatory bowel disease, diabetes.
• Current use of any psychotropic agent SSRIs, benzodiazepines, MAO Inhibitors, tricyclic antidepressants. Past pharmacotherapy is permitted if treatment ended 3 months prior to sampling.
• Current use of herbal psychoactive treatments i.e. St. John's Wort, Kava Kava, Chamomile Extract, Valeria. Past use is permitted if treatment ended 3 months prior to sampling.
• Participants receiving current psychotherapy, including cognitive behavioural therapy for an anxiety or mood disorder 3 months prior to sampling.
• Patients who currently fulfill criteria for a lifetime history of bipolar disorder, history of drug abuse, a history of schizophrenia or other psychotic disorders, delirium, dementia and amnesic and other cognitive disorders, or are in a current agitated state.
• Patients meeting criteria for current substance use disorder.
• A body mass index (BMI) \>30
• Antibiotic or probiotic use within 8 weeks of sampling. Patients beginning antibiotic treatment or probiotic use during Phase II of the study will be excluded.

Sponsors & Collaborators

• McMaster University: lead
• Hamilton Health Sciences Corporation: collaborator

Study Sites (1)

MacAnxiety Research Centre

Hamilton, Ontario, L8S 1B7, Canada

Location

Related Publications (1)

• Turna J, Grosman Kaplan K, Anglin R, Patterson B, Soreni N, Bercik P, Surette MG, Van Ameringen M. The gut microbiome and inflammation in obsessive-compulsive disorder patients compared to age- and sex-matched controls: a pilot study. Acta Psychiatr Scand. 2020 Oct;142(4):337-347. doi: 10.1111/acps.13175. Epub 2020 May 18.

  PMID: 32307692 DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Selective Serotonin Reuptake Inhibitors; Fluoxetine; Paroxetine; Fluvoxamine; Escitalopram; Citalopram; Sertraline

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Propylamines; Amines; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oximes; Hydroxylamines; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; 1-Naphthylamine; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Michael Van Ameringen, MD, FRCPC

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2014
• First Posted: November 7, 2014
• Study Start: November 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: September 2, 2020

Record last verified: 2018-03

Locations

CA (1)